The development of translated, cross-cultural patient-reported outcome measures for patients with primary ciliary dyskinesia
| Autor: | Aline Tamalet, Jane S. Lucas, Panayiotis Kouis, Lea Heisch, Claudius Werner, Claire O'Neill, Laura Behan, Bridget Contreras, Anika Lofruthe, Guillaume Thouvenin, Konstantinos Giannakou, N.W.P. Rutjes, Christine Edelbusch, Elisabeth Maurer, Helene Kobbernagel, Panayiotis K. Yiallouros, Claudia E. Kuehni, Aristoula Toliopoulou, Tamara Paff, Anu Jose, Maria C. Philipsen, Eric G. Haarman, Audrey Dunn Galvin, Alexandra L. Quittner |
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| Rok vydání: | 2016 |
| Předmět: |
medicine.medical_specialty
Pediatrics business.industry 030503 health policy & services Context (language use) language.human_language German Danish 03 medical and health sciences 0302 clinical medicine Quality of life (healthcare) Swiss German Language Family medicine Health care medicine language Patient-reported outcome 030212 general & internal medicine 0305 other medical science business Face validity |
| Zdroj: | 5.2 Monitoring Airway Disease. |
| Popis: | Introduction: Quality of life is an important parameter in the evaluation of health care and treatments. We have developed the first primary ciliary dyskinesia (PCD) health-related quality of life (HRQoL) measure for children, parents, teenagers and adults (QOL-PCD) in English. Clinical trials on rare diseases like PCD must be conducted in international settings to enrol enough patients, and outcome measures only assess the same thing if translation accounts for the socio-cultural context in which it is understood. This study aims to conduct socio-cultural translations of QOL-PCD into German, Swiss German, Danish, Dutch, French, and Greek. Methodology: We conducted (a) forward translations by 2 independent translators (b) back translation to English of the consensus versions by 1 translator, and (c) cognitive interviews of each age/language version by >5 patients to ensure the “meaning” attributed to each item is similar in different languages and cross-culturally understood. This involved 20 translators, 24 chaired meetings and interviews with 120 patients. Results: Each stage of translation involved comprehensive discussions (>2 hours), resulting in adjustments. 172 items (39-49 items across 4 age groups) were translated averaging 65 working hours per language. Cognitive interviews demonstrated face validity and no missing aspect of HRQoL were identified. International testing additionally provided valuable input on how to proceed for future improvement of QOL-PCD. Conclusion: To meet standards set by international guidelines, this extensive process has produced practical, cross-cultural and equivalent measures for future use as outcome measures in clinical trials. |
| Databáze: | OpenAIRE |
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